BioSpace
Sr. Scientist, Downstream Process Development
Base pay range: $80,000.00/yr - $110,000.00/yr
GenScript Biotech Corporation is a global biotechnology company with a focus on gene synthesis, biologics development and manufacturing, and related services. ProBio provides end-to-end CDMO services for cell and gene therapy development and manufacturing.
Overview The position reports to the Associate Director, Downstream Viral Vector Process Development & MSAT. This role is suited for a dynamic bench-focused individual who will support/lead the translation of research processes to GMP-compliant manufacturing, and will develop, scale-up, and evaluate technology transfer of viral vector processes. This is a fast-paced role with potential to lead a small team in the near future.
Responsibilities
Hands-on experimental work in the development and optimization of downstream unit operations (TFF, affinity/ion exchange/multimodal chromatography, viral clearance, sterile filtration, etc.) for viral vector manufacturing.
Plan, design, and execute AAV/LVV purification-related experiments to analyze, interpret, and report data summary packages.
Collaborate with internal and external partners to evaluate and implement new bioprocessing technologies and strategies.
Interact with cross-functional teams (Analytic, MFG, Supply Chain, Facility, QA, QC) to support process technology transfer, cGMP risk evaluation, and deviation management.
Maintain and follow detailed project timelines.
Assist in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, BLA), invention disclosures, progress reports, and publications.
Present updates to project or upper management on process development and manufacturing support activities.
Read and apply scientific literature in gene and cell therapy to inform process design and development.
Perform additional duties as needed based on business needs.
Qualifications
Bachelor’s degree with 3–7 years, or Master’s/Ph.D. with 1–3 years of relevant industry experience in Chemical/Biochemical Engineering, Biological Sciences, or a related biotech discipline; experience in gene and cell therapy product design is required. LVV and AAV process development experience is a plus.
Previous experience in viral vector process development and manufacturing is highly preferred.
Strong understanding of process scale-up and scale-down modeling.
Proficiency with Design of Experiments (DOE) and statistical analysis.
Experience in CMC regulatory affairs for FDA and EMA is a plus.
Strong organizational skills and meticulous documentation abilities.
Ability to work independently in a hands-on laboratory setting and to learn and develop new techniques.
Strong interpersonal, verbal, and written communication skills.
Results-oriented with ability to prioritize and complete tasks on time.
Collaborative mindset and ability to work in a fast-paced biotech environment.
Compensation and Benefits The salary range is $80,000 - $110,000 annually, dependent on experience.
Equal Opportunity GenScript USA Inc./ProBio Inc. is an equal opportunity/affirmative action employer committed to a diverse and inclusive workforce. It is the Company’s policy to provide equal employment opportunity without discrimination or harassment based on race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, or veteran status. The company maintains a drug-free workplace. Candidates will be contacted through verified application sources only.
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GenScript Biotech Corporation is a global biotechnology company with a focus on gene synthesis, biologics development and manufacturing, and related services. ProBio provides end-to-end CDMO services for cell and gene therapy development and manufacturing.
Overview The position reports to the Associate Director, Downstream Viral Vector Process Development & MSAT. This role is suited for a dynamic bench-focused individual who will support/lead the translation of research processes to GMP-compliant manufacturing, and will develop, scale-up, and evaluate technology transfer of viral vector processes. This is a fast-paced role with potential to lead a small team in the near future.
Responsibilities
Hands-on experimental work in the development and optimization of downstream unit operations (TFF, affinity/ion exchange/multimodal chromatography, viral clearance, sterile filtration, etc.) for viral vector manufacturing.
Plan, design, and execute AAV/LVV purification-related experiments to analyze, interpret, and report data summary packages.
Collaborate with internal and external partners to evaluate and implement new bioprocessing technologies and strategies.
Interact with cross-functional teams (Analytic, MFG, Supply Chain, Facility, QA, QC) to support process technology transfer, cGMP risk evaluation, and deviation management.
Maintain and follow detailed project timelines.
Assist in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, BLA), invention disclosures, progress reports, and publications.
Present updates to project or upper management on process development and manufacturing support activities.
Read and apply scientific literature in gene and cell therapy to inform process design and development.
Perform additional duties as needed based on business needs.
Qualifications
Bachelor’s degree with 3–7 years, or Master’s/Ph.D. with 1–3 years of relevant industry experience in Chemical/Biochemical Engineering, Biological Sciences, or a related biotech discipline; experience in gene and cell therapy product design is required. LVV and AAV process development experience is a plus.
Previous experience in viral vector process development and manufacturing is highly preferred.
Strong understanding of process scale-up and scale-down modeling.
Proficiency with Design of Experiments (DOE) and statistical analysis.
Experience in CMC regulatory affairs for FDA and EMA is a plus.
Strong organizational skills and meticulous documentation abilities.
Ability to work independently in a hands-on laboratory setting and to learn and develop new techniques.
Strong interpersonal, verbal, and written communication skills.
Results-oriented with ability to prioritize and complete tasks on time.
Collaborative mindset and ability to work in a fast-paced biotech environment.
Compensation and Benefits The salary range is $80,000 - $110,000 annually, dependent on experience.
Equal Opportunity GenScript USA Inc./ProBio Inc. is an equal opportunity/affirmative action employer committed to a diverse and inclusive workforce. It is the Company’s policy to provide equal employment opportunity without discrimination or harassment based on race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, or veteran status. The company maintains a drug-free workplace. Candidates will be contacted through verified application sources only.
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